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Sedation Management in Pediatric Patients With Acute Respiratory Failure (The RESTORE Study) (RESTORE)

27. April 2026 aktualisiert von: University of Pennsylvania

Sedation Management in Pediatric Patients With Acute Respiratory Failure

People with acute respiratory failure usually require the use of an artificial breathing machine, known as a mechanical ventilator. Sedative medications, which help keep people calm and reduce anxiety, are often prescribed for children who are on mechanical ventilators. However, the longer that sedative medications are used, the longer a child may need to remain on mechanical ventilation. This study will evaluate the effectiveness of a team approach to sedation management that aims to reduce the number of days that children with acute respiratory failure require mechanical ventilation.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

People who are hospitalized for acute respiratory failure are typically supported on mechanical ventilation, which delivers oxygen and a continuous level of pressure to the damaged lungs. Over 90% of infants and children supported on mechanical ventilation receive some form of sedation medication, which helps keep them safe, calm, and comfortable. Unfortunately, the use of sedation medications may prolong the duration of mechanical ventilation, which can lead to an increased risk for pneumonia and other complications.

Recent studies among adults in intensive care units (ICUs) have shown that when doctors and nurses work together as a team to manage the use of sedation medication, patients are taken off mechanical ventilation sooner and with fewer side effects. This team strategy includes the following:

  • Training and discussion between doctors and nurses regarding which sedative medications should be used
  • Having doctors and nurses jointly identify the patient's progress and a daily sedation medication goal for the patient
  • Having nurses use a decision-making tool to help guide changes in a patient's sedative medication dose
  • Keeping track of patient care, which allows doctors and nurses to evaluate the effectiveness of how they manage each patient's sedative medication use

This study will examine the use of the sedation management strategy for infants and children in pediatric ICUs who have acute respiratory failure and require mechanical ventilation. The purpose of the study is to evaluate whether this team approach to sedation medication management is more effective than the usual approach at reducing the amount of time children remain on mechanical ventilators. Study researchers will also examine the cost-effectiveness of this approach and associated quality of life factors.

All participants will be enrolled within 24 hours of starting mechanical ventilation and will be monitored until they receive their last dose of sedative medication, hospital discharge, or Day 28 (whichever comes first). During a 3-month baseline period, all participating pediatric ICUs will provide their usual sedation management, and study researchers will review participants' medical records on a daily basis. Each pediatric ICU will then be randomly assigned to either the control group or the team approach group. Pediatric ICUs in the control group will continue to provide usual care for sedation management. Pediatric ICUs in the team approach group will implement the team approach sedation management guidelines. For both groups, pain and sedation levels will be monitored daily, and study researchers will review participants' medical records on a daily basis, too. Six months after hospital discharge, half of the participants and their parents will complete a follow-up survey and take part in a telephone interview to assess quality of life, psychological factors, and health-related resource use.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

2449

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Alabama
      • Birmingham, Alabama, Vereinigte Staaten, 35233
        • Children's Hospital of Alabama
    • Arizona
      • Tucson, Arizona, Vereinigte Staaten, 85724
        • University Medical Center, The University of Arizona
    • California
      • Oakland, California, Vereinigte Staaten, 94609-1809
        • Children's Hospital and Research Center at Oakland
      • Orange, California, Vereinigte Staaten, 92868
        • Children's Hospital of Orange County
      • Palo Alto, California, Vereinigte Staaten, 94304-0126
        • Lucile Salter Packard Children's Hospital at Stanford
      • Sacramento, California, Vereinigte Staaten, 95817
        • University of California Davis Medical Center
      • San Francisco, California, Vereinigte Staaten, 94143
        • Children's Hospital at University of California San Francisco Medical Center
    • Connecticut
      • Hartford, Connecticut, Vereinigte Staaten, 06106
        • Connecticut Children's Medical Center
      • New Haven, Connecticut, Vereinigte Staaten, 06520-8064
        • Yale-New Haven Children's Hospital
    • Delaware
      • Wilmington, Delaware, Vereinigte Staaten, 19803
        • Nemours/Alfred I. duPont Hospital for Children
    • Florida
      • Miami, Florida, Vereinigte Staaten, 33136
        • Holtz Children's Hospital
      • Orlando, Florida, Vereinigte Staaten, 32803
        • Florida Hospital for Children
    • Illinois
      • Chicago, Illinois, Vereinigte Staaten, 60614-3363
        • Children's Memorial Hospital, Chicago
      • Oak Lawn, Illinois, Vereinigte Staaten, 60453
        • Advocate Hope Children's Hospital
    • Maryland
      • Baltimore, Maryland, Vereinigte Staaten, 21287
        • Johns Hopkins Children's Center
      • Baltimore, Maryland, Vereinigte Staaten, 21201-1595
        • University of Maryland Hospital for Children
    • Massachusetts
      • Worcester, Massachusetts, Vereinigte Staaten, 01655
        • University of Massachusetts Memorial Children's Medical Center
    • Michigan
      • Ann Arbor, Michigan, Vereinigte Staaten, 48109-0243
        • C. S. Mott Children's Hospital of the University of Michigan
    • Missouri
      • Kansas City, Missouri, Vereinigte Staaten, 84108
        • Children's Mercy Hospital, Kansas City
      • St Louis, Missouri, Vereinigte Staaten, 63110
        • St. Louis Children's Hospital
    • Nebraska
      • Omaha, Nebraska, Vereinigte Staaten, 68114
        • University of Nebraska Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, Vereinigte Staaten, 03756-0001
        • Dartmouth-Hitchcock Medical Center
    • New York
      • New Hyde Park, New York, Vereinigte Staaten, 11040
        • Cohen Children's Medical Center of New York
      • The Bronx, New York, Vereinigte Staaten, 10467
        • The Children's Hospital at Montefiore
    • North Carolina
      • Durham, North Carolina, Vereinigte Staaten, 27710
        • Duke Children's Hospital and Health Center
    • Oregon
      • Portland, Oregon, Vereinigte Staaten, 97239
        • Doernbecher Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
        • Children's Hospital of Philadelphia
    • Tennessee
      • Nashville, Tennessee, Vereinigte Staaten, 37232-9075
        • Monroe Carell, Jr. Children's Hospital at Vanderbilt
    • Texas
      • Dallas, Texas, Vereinigte Staaten, 75235
        • Children's Medical Center Dallas
      • Dallas, Texas, Vereinigte Staaten, 75230
        • Medical City Children's Hospital
    • Utah
      • Salt Lake City, Utah, Vereinigte Staaten, 84113
        • Primary Children's Medical Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

2 Wochen bis 18 Jahre (Kind, Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • At least 2 weeks of age (and at least 42 weeks post-menstrual age) and less than 18 years of age
  • Intubated and mechanically ventilated for acute lung disease

Exclusion Criteria:

  • Cyanotic heart disease with unrepaired or palliated right to left intracardiac shunt
  • History of single ventricle at any stage of repair
  • Congenital diaphragmatic hernia or paralysis
  • Primary pulmonary hypertension
  • Critical airway or anatomical obstruction of the lower airway
  • Ventilator dependent upon pediatric ICU admission
  • Neuromuscular respiratory failure
  • Spinal cord injury above the lumbar region
  • Pain managed by patient-controlled analgesia or epidural catheter
  • Patient transferred from an outside ICU where sedatives had already been administered for more than 24 hours
  • Family or medical team has decided not to provide full support
  • Enrolled in any other critical care interventional clinical trial concurrently or in the 30 days before study entry
  • Known allergy to any of the study medications
  • Pregnancy

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 1
Participants will receive care at a pediatric ICU that is continuing the usual approach to sedation management.
Verhalten: Usual approach to sedation management
The pediatric ICU will continue its usual approach to sedation management.
Experimental: 2
Participants will receive care at a pediatric ICU that is implementing the team approach to sedation management.
Verhalten: Team approach to sedation management

The team approach to sedation management includes the following:

  • Team education and consensus on the use of sedatives
  • Team identification of the patient's trajectory of illness and daily prescription of a sedation goal
  • A nurse-implemented goal-directed comfort algorithm that guides moment-to-moment titration of opioids and benzodiazepines
  • Team feedback on sedation management performance

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Duration of mechanical ventilation
Zeitfenster: Measured from the time of endotracheal intubation to the end of scheduled sedation therapy, hospital discharge, or Day 28 (whichever comes first)
Measured from the time of endotracheal intubation to the end of scheduled sedation therapy, hospital discharge, or Day 28 (whichever comes first)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Time to recovery of acute respiratory failure
Zeitfenster: Measured from the time of endotracheal intubation to when participants first meet the criteria to be tested for extubation readiness
Measured from the time of endotracheal intubation to when participants first meet the criteria to be tested for extubation readiness
Duration of weaning from mechanical ventilation
Zeitfenster: Measured from the time participants meet the criteria to be tested for extubation readiness until the time of the first successful extubation (defined as extubation for more than 24 hours)
Measured from the time participants meet the criteria to be tested for extubation readiness until the time of the first successful extubation (defined as extubation for more than 24 hours)
Occurrence of adverse events
Zeitfenster: Measured for the duration of the study
Measured for the duration of the study
Detection of life-threatening neurological events
Zeitfenster: Measured for the duration of the study
Measured for the duration of the study
Total sedative exposure
Zeitfenster: Measured for the duration of the study
Measured for the duration of the study
Occurrence of iatrogenic withdrawal symptoms
Zeitfenster: Measured for the duration of the study
Measured for the duration of the study
Pediatric ICU and hospital length of stay
Zeitfenster: Measured for the duration of the study
Measured for the duration of the study
Hospital costs
Zeitfenster: Measured for the duration of the study
Measured for the duration of the study
Study implementation costs and cost-effectiveness
Zeitfenster: Measured for the duration of the study
Measured for the duration of the study
In-hospital mortality
Zeitfenster: Measured for the duration of the study
Measured for the duration of the study
Post-discharge quality of life and emotional health
Zeitfenster: Measured 6 months after pediatric ICU discharge
Measured 6 months after pediatric ICU discharge

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Pennsylvania

Mitarbeiter

National Heart, Lung, and Blood Institute (NHLBI)

Ermittler

  • Hauptermittler: Martha A.Q. Curley, RN, PhD, University of Pennsylvania
  • Studienleiter: David Wypij, PhD, Director, Statistics and Data Coordinating Center; Children's Hospital Boston

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Januar 2009

Primärer Abschluss (Tatsächlich)

1. Dezember 2013

Studienabschluss (Tatsächlich)

1. Dezember 2013

Studienanmeldedaten

Zuerst eingereicht

19. Dezember 2008

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. Dezember 2008

Zuerst gepostet (Geschätzt)

23. Dezember 2008

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. April 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 611
  • U01HL086622 (US NIH Stipendium/Vertrag)
  • U01HL086649 (US NIH Stipendium/Vertrag)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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